BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - NAIL (TITANIUM ENDOMEDULLARY)

    MDR report key: 5623917 · Received May 2, 2016

    Report

    Report Number
    2520274-2016-12178
    Event Type
    Injury
    Date Received
    May 2, 2016
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    KETTLER, M., ET AL (2007). FLEXIBLE INTRAMEDULLARY NAILING FOR STABILIZATION OF DISPLACED MIDSHAFT CLAVICLE FRACTURES TECHNIQUE AND RESULTS IN 87 PATIENTS. ACTA ORTHOPADICA, 3; 424-429. THIS REPORT IS FOR AN UNKNOWN NAIL (TITANIUM ENDOMEDULLARY), UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: KETTLER, M., ET AL (2007). FLEXIBLE INTRAMEDULLARY NAILING FOR STABILIZATION OF DISPLACED MIDSHAFT CLAVICLE FRACTURES TECHNIQUE AND RESULTS IN 87 PATIENTS. ACTA ORTHOPADICA, 3; 424-429. GERMANY. THE RESULTS OF A NEW MINIMALLY INVASIVE PROCEDURE BASED ON THE USE OF ELASTIC, STABLE INTRAMEDULLARY TITANIUM NAILS WERE ANALYZED. FROM JANUARY 2001 TO SEPTEMBER 2005, 95 PATIENTS WITH MID SHAFT FRACTURES WERE TREATED BY EIGHT DIFFERENT SURGEONS USING ELASTIC TITANIUM NAIL (SYNTHES, (TEN) OR DEPUY (ECMES). THE ARTICLE DID NOT IDENTIFY WHICH NAILS WERE IMPLANTED IN THE PATIENTS. THE AVERAGE PATIENT AGE WAS 38 YEARS (RANGE 15-74) AND INCLUDED 68 MALES AND 32 FEMALES. OF THE 95 PATIENTS, 8 PATIENTS WERE LOST TO FOLLOW-UP NO EARLY COMPLICATIONS WERE REPORTED IN THESE PATIENTS. EIGHTY-SEVEN PATIENTS WERE EVALUATED AFTER AN AVERAGE FOLLOW-UP PERIOD OF 13 MONTHS (RANGE 6-28). OUTCOME WAS ASSESSED USING DASH SCORE, SHOULDER FUNCTION WAS MEASURED USING SELF-REPORTED CONSTANT SCORE. COMPLICATIONS: 4 PATIENTS HAD NAIL MIGRATIONS WHICH MADE EARLIER IMPLANT REMOVAL NECESSARY. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN NAIL (TITANIUM ENDOMEDULLARY), UNKNOWN QUANTITY AND LOT NUMBER A COPY OF THE LITERATURE ARTICLE (ABSTRACT) WILL BE SUBMITTED WITH THE MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278755 UNKNOWN - NAIL (TITANIUM ENDOMEDULLARY) ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention